Manage labeling documentation projects, ensure compliance with regulatory standards, and improve labeling processes under senior management guidance.
JOB RESPONSIBILITIES
SKILLS
QUALIFICATIONS
EXPERIENCE
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
- Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
- Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate.
- Produces other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation.
- Performs QC check of other colleagues' work.
- Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
- Meets defined targets on productivity, quality and compliance, as set by and overseen by management.
SKILLS
- Basic knowledge/understanding of the principles and concepts of labeling.
- Knowledge of key regulatory and labeling principles and local regulations.
- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures.
- Fluency in English language important however multi-language skills are advantageous.
- Clear and effective written and verbal communications.
- Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.
QUALIFICATIONS
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
EXPERIENCE
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations. (Preferred)
- Demonstration of attention to detail and problem-solving skills.
- Proven technical aptitude and ability to quickly learn new software.
- Proven technical aptitude and ability to quickly learn regulations and standards.
- 'Hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.
- Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label
- Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
- Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages. (Preferred)
- Demonstrated project management, attention to detail and problem-solving skills. (Preferred)
- Proven strength in logical, analytical and writing ability essential
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
Top Skills
Ms Access
Excel
Ms Sharepoint
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